Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer (PACT-17)

San Donato Group (GSD)

Status and phase: Terminated; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: gemcitabine; Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01167738

2010-020979-23 (EudraCT Number)

CDR0000681691

PACT-17 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.

PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.

Full description

OBJECTIVES:

Primary

• To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.

Secondary

• To assess the overall survival of patients treated with this regimen.
• To assess the response rate in patients treated with this regimen.
• To assess the duration of response in patients treated with this regimen.
• To assess the toxicity in patients treated with this regimen.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma

  • Metastatic (stage IV) disease

• Measurable disease

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Not pregnant or nursing
• Adequate bone marrow, liver and kidney function
• No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
• No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
• No alcohol abuse

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or metformin
• No other concurrent experimental drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PEXG regimen + metformin

Experimental group

Description:

cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28

Treatment:

Drug: metformin

Drug: epirubicin

Drug: cisplatin

Drug: capecitabine

Drug: gemcitabine

PEXG regimen

Active Comparator group

Description:

cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15

Treatment:

Drug: epirubicin

Drug: cisplatin

Drug: capecitabine

Drug: gemcitabine